P1179: PROGNOSIS OF PATIENTS WITH AGGRESSIVE REFRACTORY B-NHL TREATED WITH GLOFITAMAB IN REAL CLINICAL PRACTICE
Authors: Liudmila Fedorova, Olesia Smykova, Lepik Kirill, Vladislav Markelov, Marina Popova, Elena Kondakova, Ivan Moiseev, Natalia Mikhailova, Alexander Kulagin
Journal: HemaSphere (2023)

Topic: 19. Aggressive Non-Hodgkin lymphoma - Clinical Background: Previous data of clinical trials demonstrated high efficacy of bispecific antibody glofitamab (G) in the therapy of patients with refractory aggressive B-cell non-Hodgkin lymphomas (B-NHL). More than 70% of patients who achieve CR maintain a response within a year according to clinical studies [M. Hutchings et al., 2021]. At the moment, it is required to study this issue in the framework of real clinical practice. Aims: To analyze the prognosis of patients with aggressive refractory B-NHL treated with glofitamab in real clinical practice. Methods: This study included 24 pts with r/r B-NHL who were treated with G within the Russian Named Patient Program. G was prescribed in escalated regimen: 2.5 mg D8C1, 10 mg D15C1, 30 mg D1C2-12. Anti-CD20 antibody was administrated 1 week before G therapy initiation. Efficacy was analyzed by PET-CT after C3, C7 and C12 using Lugano criteria. Adverse events (AEs) were graded according to NCI CTCAE 5.0. Results: Median age at G initiation was 47 (27-70), male/female ratio - 8/16 (33/67%). Median number of therapy lines before G was 3 (3-8). Prior autologous SCT was performed in 6 (25%) pts, polatuzumab vedotin in 7 (29%) pts. All patients had active disease at G initiation, ECOG>1 was in 6 (25%) pts, B symptoms in 5 (21%) pts and bulky disease in 7 (29%) pts. Median follow up was 11 (1-21) months. At analysis all pts discontinued therapy due to therapy completion (n=9, 38%), PD (n=8, 33%), severe COVID-19 (n=5, 21%) and other reason (n=2, 8%). Median number of cycles was 7 (2-12). Overall response rate was 71% (complete response (CR) n=14, 58%; partial response n=3, 13%). Nine patients died during G therapy including 6 (18%) pts due to PD and 3 pts - severe COVID-19. Median OS in all patients was not reached, 1-year OS was 62.5% (CI 95%: 40.3-78.4); median PFS was 10.8 months (CI 95%: 3.7-NA), 1-year PFS 50% (CI 95%: 29.1-67.8). Fourteen patients (58%) achieved CR during G therapy. Median follow up in this group was 12 (8-21) months. At the moment of analysis 1 of 14 pts had a disease relapse and started additional therapy and 1 pt died due to severe COVID-19 pneumonia in CR. Median OS and PFS in patients with CR were not reached, 1-year OS was 92.9% (CI 95%: 59.1-99), 1-year PFS 85.7% (CI 95%: 53.9-96.2). AEs were presented in 24 (100%) pts including grade 3-4 AEs in 13 (62.5%) and grade 5 AEs (COVID-19) in 3 (12.5%) pts. CRS developed in 13 (54%) pts (grade 1-2 n=12, grade 3 n=1). Viral infections occurred in 14 (58%) pts including COVID-19, cytomegalovirus and Varicella zoster virus. In all patients who had an insufficient response to G therapy the allo-HSCT was considered. However, at the moment of analysis only 1 patient was undergone allo-HSCT after additional therapy. Summary/Conclusion: G therapy demonstrated favorable activity with frequent and durable CR in real practice. At the same time, adverse events were observed in all patients, therefore clinical caution is needed during G treatment considering risk of CRS syndrome and cases of severe viral infections. Keywords: Lymphoma, Non-Hodgkin’s lymphoma, Immunotherapy, Bispecific